Dentalez, Inc.
Lancaster, PA, US
Dentalez, Inc. appears in FDA device records in Lancaster, PA. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 7
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 7 510(k) clearances for Dentalez, Inc. between 2007 and 2020. The busiest year on record is 2007, with 1. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2009 | 1 |
| 2012 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K192412 | SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece | EFB | Substantially Equivalent | |
| K173465 | Concentrix MX-AC High-Speed Handpiece | EFB | Substantially Equivalent | |
| K162397 | Titan 3 Low Speed Angle Attachments | EGS | Substantially Equivalent | |
| K153411 | 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece | EFB | Substantially Equivalent | |
| K113301 | CONCENPIECE,HIGH-SPEED HANDPIECE SERIES | EFB | Substantially Equivalent | |
| K093072 | STARCARE HANDPIECE MAINTENANCE UNIT | EFB | Substantially Equivalent | |
| K070869 | PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422 | EFB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain